MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE RELOADABLE CLIP APPLICATOR

Model Number	HX-810UR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the single use reloadable clip applicator was not detaching from the clip fixing device when trying to close the clip and the inside wire clip applicator breaks from the handle and gets loose and does not release the clip.The issue occurred during preparation for use for a therapeutic procedure.There were no reports of patient harm.Related patient identifier is (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained (identified via b5).If additional / relevant information is identified, a future report will be submitted.
Event or Problem Description
Additional information obtained identifies: the issue was resolved without needing to return the device.The hemostasis procedure was resolved with a resolution/rescue clip from boston scientific, with a small delay because the team had to resolve our broken product and solve bleeding with resolution clip from boston scientific.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was manufactured in november 2022, but the specific date is unknown.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the event (the clip did not come off the fixture) was caused by the operation wire coming out from the caulking part, which caused the clip to not come off the fixture.The disconnection of the operating wire occurred due to the following mechanism: 1.Due to some influence during clipping, the amount of operating force increased.2.An excessive tensile load was applied to the operating wire due to the increased operating force.3.The operation wire came out from the caulking part due to the load exceeding the resistance.However, since the device was not inspected, the exact cause could not be determined.The event can be prevented by following the instructions for use which state: ·"do not apply excessive bending, pulling or pressure to this product.It may lead to equipment damage or functional deterioration.·do not round the insertion tube smaller than 20 cm in diameter.The insertion tube may be damaged.·do not use excessive force to operate each part.It may lead to damage of rotating clip device and clip." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE RELOADABLE CLIP APPLICATOR
• Common Device Name: CLIP APPLICATOR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17638370
• Report Number: 9614641-2023-01246
• Device Sequence Number: 7978636
• Product Code: PKL
• UDI-Device Identifier: 04953170390739
• UDI-Public: 04953170390739
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K183590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-810UR
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/28/2023; 01/12/2024
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/06/2023; 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown